PA Imaging
Advancing Breast Imaging Beyond Morphology

What challenges exist in breast cancer detection using traditional morphology-based imaging approaches?

Breast cancer remains the most common malignancy among women in the Netherlands. One in seven women develops the disease, and more than 3,000 die each year. Around 110,000 women undergo biopsies annually, following screening results or self-detected abnormalities. Yet about half of the results are benign. Earlier and more accurate detection is critical to improving these outcomes and reducing unnecessary biopsies.

PA Imaging addresses this gap.

A spin-off of University Twente, the company is advancing breast cancer diagnostics with 3D PAUS Mammography, the first clinically integrated system that combines 3D photoacoustic and ultrasound imaging. Photoacoustic imaging at clinically relevant depths exceeding five centimetres enables the technology to visualise more than 90 per cent of breast volume in a single acquisition cycle.

Traditionally, evaluation progresses from mammography and 2D ultrasound to BI-RADS classification and biopsy. False-positive rates were approaching two-thirds in the United States and about half in the Netherlands. Radiation exposure, painful breast compression and operator dependency further complicate the imaging process. Conventional modalities also remain largely morphology-driven, offering limited insight into the biological processes that distinguish malignant from benign tissue.

“By adding 3D PAUS images to the existing diagnostic pathway, we aim to better equip radiologists to discriminate between benign and malignant lesions,” says Prof. Dr Paul H.J. Nederkoorn, managing director and founder.

After a decade of translational research, PA Imaging has progressed from early laboratory prototypes to the near-commercial PAM3+ system, advancing toward CE marking and first commercial deployment.

From Morphology to Biological Insight

How does 3D PAUS mammography provide functional insight beyond traditional structural imaging methods?

3D PAUS Mammography introduces functional insight by generating volumetric imaging data with small isotropic voxels. Used alongside mammography and 2D ultrasound, the system adds biological context that can improve diagnostic specificity. This may be particularly valuable for women with dense glandular tissue and for younger patients, for whom radiation-free imaging presents strategic advantages.

By combining 3D photoacoustic imaging with volumetric ultrasound at clinically relevant depths, the system captures vascular biology and tissue structure within a single acquisition cycle. This dual-modality approach allows radiologists to evaluate structural and functional information simultaneously.

Designed to integrate into established BI-RADS workflows, 3D PAUS requires no major infrastructure changes. Radiologists interpret PAUS images alongside mammography and ultrasound data, strengthening diagnostic confidence while preserving familiar clinical routines. The examination operates without ionising radiation, breast compression or contrast administration, avoiding numerous limitations associated with conventional breast imaging and helping reduce patient burden. During imaging, the patient lies face down while the breast is immersed in temperature-controlled water, allowing for stable positioning and a painless scan that averages approximately five minutes per breast.

“3D PAUS mammography is non-invasive and truly women-friendly. It offers radiation-free imaging, eliminates the need for breast compression and enables contrast-free examination,” says Prof. Dr Nederkoorn.

Imaging can also be performed more frequently during neoadjuvant chemotherapy, as no gadolinium contrast is required. Unlike contrast-enhanced MRI, which is typically limited to pre- and post-treatment evaluation due to contrast administration constraints, 3D PAUS enables repeated functional assessment of tumour vascularity and treatment response.

Earlier identification of insufficient therapeutic response may allow oncologists to adjust treatment regimens sooner, potentially avoiding ineffective chemotherapy cycles and reducing surgical burden.

Enhancing Lesion Detection through Vascular Insight

Why is vascular and acoustic data integration important for improving lesion classification accuracy?

At a technical level, the system uses nanosecond laser pulses across multiple wavelengths to excite oxygenated and deoxygenated haemoglobin within blood vessels. When light energy is absorbed, the tissue undergoes thermoelastic expansion, generating acoustic waves that are detected by sensitive ultrasound transducers. These same transducers can also emit ultrasound pulses, enabling the system to alternate between photoacoustic detection and ultrasound transmission within the same acquisition cycle.

Malignant lesions frequently demonstrate angiogenesis and elevated acoustic velocity. 3D PA images visualise vascular density and architecture with anatomical detail, while 3D ultrasound quantifies speed-of-sound values across tissue planes. When a localised 3D region exhibits high speed-of-sound values together with increased vessel density and atypical vascular architecture, it may indicate a higher likelihood of malignancy.
This convergence of vascular and structural information is contributing to the development of an emerging diagnostic lexicon unique to 3D PAUS imaging. Multispectral photoacoustic acquisition across multiple laser wavelengths further supports differentiation between cystic and solid lesions, offering additional functional cues during interpretation.

Economic and Operational Considerations

In what way does PAUS imaging improve cost efficiency and accessibility compared to MRI systems?

3D PAUS offers a cost-efficient alternative to MRI-based breast imaging systems that require nearly €2 million in capital expenditure along with substantial infrastructure modifications.

The PAUS platform can be installed in standard hospital rooms and transported through the existing structure and elevators. Scenario modelling suggests potential annual healthcare savings for the Netherlands of approximately €37 million across diagnostic and screening applications.

At the hospital level, projected return on investment for 3D PAUS is estimated at 20.4 per cent compared with 15.8 per cent for MRI systems. The higher projected ROI reflects lower capital expenditure, reduced staffing requirements, elimination of contrast-agent dependency and greater procedural flexibility. Shorter amortisation timelines may make adoption feasible beyond tertiary academic centres, including regional hospitals.

Laying the Foundation for Next-Gen Imaging

Clinical development is advancing under an Investigational Medical Device Dossier. A prospective clinical trial scheduled for 2026 will enrol more than 1,000 patients across BI-RADS categories to support CE marking of the PAM3+ system.

Achieving CE certification is a key milestone for PA Imaging, enabling commercial sales, reimbursement discussions and structured European market entry.

AI contributes to the ongoing refinement of 3D image reconstruction, while a centralised processing architecture supports standardised volumetric output through secure private cloud infrastructure.

The development roadmap also includes cost optimisation toward a next-generation PAM3++ platform, as well as the establishment of an international value-added reseller network to support broader global deployment from 2029 onward.

The global breast imaging market was valued at approximately €4.8 billion in 2024 and is projected to grow at nearly nine per cent annually. Within this expanding landscape, 3D PAUS is initially positioned as an adjunct modality that enhances diagnostic specificity and therapy monitoring. The technology is being evaluated for the longer term as a radiation-free screening alternative for women with dense breast tissue and younger populations.

As PA Imaging advances toward CE marking, the focus remains on integrating 3D PAUS into existing diagnostic workflows to support greater diagnostic specificity while preserving patient comfort. This approach has contributed to its recognition as the Top Breast Cancer Diagnostic Device of the Year 2026, reflecting growing interest in technologies that strengthen diagnostic precision and support improved patient outcomes.